ACETAMINOPHEN EXTRA STRENGTH- acetaminophen 500mg/15ml solution

Acetaminophen Extra Strength by

Drug Labeling and Warnings

Acetaminophen Extra Strength by is a Otc medication manufactured, distributed, or labeled by Aldama Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL-teaspoonful)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• Temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take

• more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using the product.

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

DO NOT USE

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

ASK DOCTOR

Ask a doctor before use if your childhas liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have taking the blood thinning drug warfarin.

WHEN USING

When using this product do not exceed recommended dose

STOP USE

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or conbtact a Poison Control Center right away.  Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

If pregnant or breast-feeding

ask a health professional before use

DOSAGE & ADMINISTRATION

Directions

• do not take more than directed

• Age: DOSE
• Adults and children 12 years of age and older: Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours
• Children under 12 years: Do not use

OTHER SAFETY INFORMATION

Other information

• store at room temperature between 15-30°C (59-86°F)
• protect from freezing
• protect from light
• TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing

INACTIVE INGREDIENT

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

QUESTIONS

Question or Comments?

call 305-592-9216 or info@aldamapharm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen 500mg/15ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73564-817
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73564-817-08	1 in 1 BOX	01/01/2026
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/01/2026

Labeler - Aldama Pharmaceuticals, Inc (119484030)

Establishment
Name	Address	ID/FEI	Business Operations
Aldama Pharmaceuticals, Inc		119484030	manufacture(73564-817)